Appeals Court Hears Case On Breast Cancer Gene Patents

The U.S. Court of Appeals for the Federal Circuit heard arguments today that could decide the future of the biotech industry, in a case over whether genes can be patented.

The case is one brought in 2009 against a Utah-based company called Myriad Genetics. Myriad had patents on two genes, called BRCA1 and BRCA2. Mutations in these genes can increase a woman's risk of breast and ovarian cancer.

A complaint filed by the Association for Molecular Pathology, three other professional organizations, several doctors and advocacy groups said that the patents on the genes were granted improperly, because the genes weren't invented by Myriad Genetics. The suit names the U.S. patent and Trademark Office as well as Myriad and the directors of the University of Utah Research Foundation.

The case started in the Southern District of New York, where the trial court agreed with the plaintiffs and said the patents were improperly granted in the first place. The New York court also said that the patents for methods of measuring the effects of the genes and testing for them were invalid also.

Kristin Yohannan, an attorney who specializes in the biotechnology industry at Morrison & Foerster, a Washington, D.C. law firm that is not involved in the case, said a judgment for the plaintiffs would fundamentally alter the way the biotechnology industry operates, because so much is dependent on patented genes. In addition, a ruling for the plaintiffs would overturn three decades of PTO policy, which held that genes are patentable.

The argument for patenting genes is that when they are isolated from the genome in which they function they are altered in a way that can be patented. Yohannan said one analogy brought up at the hearing was an object made of wood. Patents aren't given for trees, or wood, but something made from wood can be patented.

The counterargument is that genes - at least those found in living organisms - aren't created by the patent holder out of some other substance. They are chemicals that behave the same way when they are taken out of their context. A process for separating genes might be patentable, but the gene itself is not.

Yohannan noted that the plaintiff's lawyers said if the claim that genes were radically altered by separating them from the genome were true, then it wouldn't make any sense to use them to test for a person's potential for cancer, since cancer happens as a result of the gene being in the body.

The three judges hearing the case are Alan D. Lourie, Kimberly A. Moore and Sharon Prost. Lourie was appointed by George H. W. Bush, while Moore and Prost were George W. Bush appointees. Yohannan said Lourie has a more technical background, having a master's degree in organic chemistry, and he seems to think genes are patentable. The other two judges asked about the possibility of sequencing one's own genome and used various analogies to try to determine what occurs in nature - and is thus not patentable - and what does not.

The case called Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al.. A decision should come in the next few months.